title: Performing Drug Safety Research During Pregnancy and Lactation: Biomedical HIV Prevention Research as a Template.
abstract: Evidence-based guidance regarding use of nearly all pharmaceuticals by pregnant and lactating women is limited. Models for performing research may assist in filling these knowledge gaps. Internationally, reproductive age women are at high risk of human immunodeficiency virus (HIV) acquisition. Susceptibility to HIV infection may be increased during pregnancy, and risk of maternal-child transmission is increased with incident HIV infection during pregnancy and lactation. A multidisciplinary meeting of experts was convened at the United States National Institutes of Health to consider paradigms for drug research in pregnancy and lactation applicable to HIV prevention. This report summarizes the meeting proceedings and describes a framework for research on candidate HIV prevention agent use during pregnancy and lactation that may also have broader applications to other pharmaceutical products.
authors.affiliation: 1 Division of Reproductive Infectious Diseases, Department of Obstetrics, Gynecology, and Reproductive Sciences, Magee-Womens Hospital of the University of Pittsburgh Medical Center , Pittsburgh, Pennsylvania.|2 Microbicide Trials Network, Magee-Womens Research Institute , Pittsburgh, Pennsylvania.
authors.forename: Richard H
authors.initials: RH
authors.lastname: Beigi
authors.affiliation: 2 Microbicide Trials Network, Magee-Womens Research Institute , Pittsburgh, Pennsylvania.|3 Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health , Baltimore, Maryland.
authors.forename: Lisa
authors.initials: L
authors.lastname: Noguchi
authors.affiliation: 4 Office of AIDS Research, National Institutes of Health , Bethesda, Maryland.
authors.forename: Gina
authors.initials: G
authors.lastname: Brown
authors.affiliation: 5 National Institute of Allergy and Infectious Diseases, Division of AIDS, National Institutes of Health , Bethesda, Maryland.
authors.forename: Jeanna
authors.initials: J
authors.lastname: Piper
authors.affiliation: 6 Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health , Bethesda, Maryland.
authors.forename: D Heather
authors.initials: DH
authors.lastname: Watts
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D054316:Biomarkers, Pharmacological; D035843:Biomedical Research; D001942:Breast Feeding; D003226:Congresses as Topic; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007774:Lactation; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000517:prevention & control*
chemical_list: D019380:Anti-HIV Agents; D054316:Biomarkers, Pharmacological